A Study of Dayingpian Treating Bipolar Disorder

Last updated: October 18, 2022
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bipolar Disorder

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT05247593
SHDY2021CR2110C
  • Ages 14-65
  • All Genders

Study Summary

The main purpose of this cohort study is to evaluate the efficiency and safety of Dayingpian to provide evidence-based medical evidence for the subsequent drug development.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meets the International Classification of Diseases-10(ICD-10) criteria for BipolarDisorder.
  2. Outpatients or inpatients in Shanghai Mental Health Center.
  3. Male or female subjects aged 14-65 years.
  4. education of Junior high school or above.
  5. The patient fully understands and signs the informed consent form.

Exclusion

Exclusion Criteria:

  1. Apparent violent aggression/suicide within the last two weeks.
  2. Other patients that the investigator believes should not be included in the study.

Study Design

Total Participants: 308
Study Start date:
August 01, 2022
Estimated Completion Date:
September 30, 2024

Study Description

Dayingpian is a kind of formula in traditional Chinese medicine with the effect of promoting blood circulation and reducing blood stasis. It has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. However, there is not yet much high-quality evidence of the clinical effectiveness of Dayingpian treatment. In this study, we conduct a prospective, real-world longitudinal cohort study at Shanghai Mental Health Center in China to investigate the efficacy and safety of Dayingpian for bipolar disorder patients. The observation period is 12 weeks and all participants are evaluated every 4 weeks.

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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